Scp776 for Stroke

(ARPEGGIO Trial)

Recruiting at 14 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Silver Creek Pharmaceuticals

Must not be taking: Anticoagulants

Disqualifiers: Intracerebral hemorrhage, Poor circulation, End stage kidney, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 44

120 Participants Needed

Trial Summary

What is the purpose of this trial?

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study of the Safety and Neuroprotective Capacity of Scp776 in Subjects Undergoing Endovascular Thrombectomy for Acute Ischemic Stroke

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking a chronic anticoagulant like warfarin or apixaban.

Will I have to stop taking my current medications?

If you are taking a chronic anticoagulant (blood thinner), you may need to stop unless certain conditions are met. However, chronic use of anti-platelet drugs is allowed. The trial protocol does not specify other medication restrictions.

What data supports the idea that Scp776 for Stroke is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Scp776 for Stroke as a treatment. Instead, it mentions various studies comparing other treatments like acupuncture, L-DOPA, and NeuroAiD to placebos. These studies focus on different therapies and drugs for stroke recovery, but none specifically highlight Scp776 as an effective option. Therefore, there is no direct evidence from the provided information that Scp776 is effective for stroke treatment. ^{1 2 3 4 5}

What safety data exists for the treatment SCP-776 for stroke?

The provided research does not mention SCP-776 or any of its alternative names directly. However, it discusses the safety of GV150526, a glycine antagonist at the NMDA receptor complex, in acute stroke patients. GV150526 was generally well tolerated in early human studies, with some patients experiencing asymptomatic hyperbilirubinemia, leading to a reduction in the maintenance dose during the trial. The study concluded that GV150526 was generally well tolerated, justifying further formal efficacy studies. ^{6 7 8 9 10}

Is the treatment Scp776 for Stroke, and the treatment Placebo, scp776 (also known as: Control, Dummy Treatment, SCP-776) a promising treatment?

Based on the information provided, there is no evidence to suggest that Scp776, also known as Control, Dummy Treatment, or SCP-776, is a promising treatment for stroke. The relevant research articles do not mention Scp776 or provide any data supporting its effectiveness for stroke treatment. ^{11 12 13 14 15}

How is the drug SCP-776 different from other stroke treatments?

The clinical trial for SCP-776 is unique because it involves a placebo-controlled study, which helps determine the drug's effectiveness compared to no active treatment. This approach is crucial for understanding the true impact of SCP-776 on stroke recovery. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for adults over 18 with a body weight under 150 kg who are experiencing a severe, disabling stroke and are set to undergo endovascular thrombectomy. They must have had symptoms start within the last 16 hours and not be on certain blood thinners or have conditions that could interfere with the study.

Inclusion Criteria

The time between when you last felt well and when you join the study is less than 16 hours.

I am 18 years old or older.

My body weight is under 150 kg.

Exclusion Criteria

I am on long-term blood thinners like warfarin or apixaban.

I have end-stage kidney disease.

I do not have arterial conditions like aortic dissection or carotid stent that would interfere with blood flow restoration.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Sequential dose escalation with scp776 or placebo in 3 cohorts

7 days

Daily visits for 7 days

Treatment Part B

Dose expansion with chosen scp776 therapeutic dose or placebo

7 days

Daily visits for 7 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Visits at Day 30 and Day 90

Treatment Details

Interventions

• Placebo
• scp776

Trial Overview The study tests Scp776 at two different doses (1.9 mg/kg and 3.8 mg/kg) against a placebo in patients having an acute ischemic stroke to see if it's safe and can protect brain cells. It's randomized, meaning participants are put into groups by chance, double-blind so neither doctors nor patients know who gets what treatment.

Participant Groups

Group I: scp776 (4.8 mg/kg) Experimental Treatment 2 Interventions

Cohort 3 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 4.8 mg/kg

Group II: scp776 (3.8 mg/kg) Experimental Treatment 2 Interventions

Cohort 2 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 3.8 mg/kg

Group III: scp776 (1.9 mg/kg) Experimental Treatment 2 Interventions

Cohort 1 dose regimen: Intravenous (IV) injection(s) over 2 minutes - 1.9 mg/kg

Group IV: Placebo Placebo Group 1 Intervention

Volume Matched Placebo (normal saline)

Who Is Running the Clinical Trial?

Silver Creek Pharmaceuticals

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

Among 178 studies analyzed, six experimental training programs (ETPs) were found to significantly improve upper extremity motor recovery in stroke patients, including constraint-induced movement therapy and mirror therapy, with effect sizes indicating moderate to strong benefits.

For lower extremity recovery, six ETPs, such as body-weight-supported treadmill training and caregiver-mediated training, also showed significant effectiveness; however, none of the ETPs demonstrated superiority over conventional training programs, suggesting that while they are beneficial, they may not be better than standard rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Superiority of Rehabilitative Treatments in Enhancing Motor Recovery Within 6 Months Poststroke: A Systemic Review. Lin, IH., Tsai, HT., Wang, CY., et al.[2019]

In a pilot study involving 10 chronic stroke patients, a 5-week treatment with L-DOPA significantly improved walking speed and manual dexterity, indicating its potential efficacy in enhancing motor recovery.

The treatment also lengthened the cortical silent period in the affected hemisphere, suggesting that L-DOPA may help modulate motor cortical excitability, which could be important for recovery after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term levodopa administration in chronic stroke patients. A clinical and neurophysiologic single-blind placebo-controlled cross-over pilot study. Acler, M., Fiaschi, A., Manganotti, P.[2022]

In a study involving 18 participants with low-back pain, both active chiropractic adjustments and sham treatments led to improvements in pain and well-being, but active treatments generally resulted in greater benefits.

Interestingly, 57% of participants who received the sham treatment believed it had a positive effect, highlighting the potential for placebo effects in chiropractic care and the importance of blinding in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary study of the effects of a placebo chiropractic treatment with sham adjustments. Hawk, C., Azad, A., Phongphua, C., et al.[2019]

In a study involving 92 stroke patients, acupuncture did not show significant efficacy over a placebo treatment (mock TENS) in aiding stroke recovery, with no notable differences in recovery outcomes at 12 and 52 weeks.

However, there was a temporary improvement in muscle power scores in the acupuncture group at 3 weeks, suggesting that while acupuncture may not be more effective overall, it could have short-term benefits for muscle recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of acupuncture in defined aspects of stroke recovery: a randomised, placebo controlled single blind study. Hopwood, V., Lewith, G., Prescott, P., et al.[2021]

The CHIMES trial is investigating the long-term effects of the traditional Chinese medicine MLC601 (NeuroAiD) on reducing neurological deficits and improving functional outcomes in patients with acute ischemic stroke, with a focus on those with moderate severity (NIHSS scores of 6 to 14).

This extension study aims to assess the efficacy of NeuroAiD over a 2-year period, with a robust sample size of 1,100 participants, and is designed to provide strong evidence regarding its potential benefits compared to placebo in stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese medicine NeuroAiD efficacy stroke recovery-extension study (CHIMES-E study): an observational multicenter study to investigate the longer-term efficacy of NeuroAiD in stroke recovery. Venketasubramanian, N., Young, S., Tay, SS., et al.[2013]

Currently, the only approved pharmacological treatment for acute ischemic stroke is tissue plasminogen activator, which must be administered within 3 hours of stroke onset, highlighting the urgent need for new therapies.

The FDA allows for the approval of new stroke treatments through a combination of a large phase III trial and supportive phase IIB trials that demonstrate effects on imaging biomarkers, potentially streamlining the development of effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New pathways for evaluating potential acute stroke therapies. Fisher, M., Cheung, K., Howard, G., et al.[2008]

GV150526, a selective glycine site antagonist, was found to be well tolerated in patients with acute stroke, with a similar incidence of serious adverse events compared to placebo, although mild side effects were more common in the treatment group.

Preliminary results indicated that patients treated with GV150526 showed better outcomes at 4 weeks post-stroke, but the studies were not designed to definitively prove statistical significance due to differences in baseline neurological severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II studies of the glycine antagonist GV150526 in acute stroke : the North American experience. The North American Glycine Antagonist in Neuroprotection (GAIN) Investigators. [2019]

In a rat model of stroke, the non-competitive NMDA antagonist MK-801 caused significantly more intense psychomimetic effects in ischemic rats compared to non-ischemic rats, suggesting that stroke patients may be more sensitive to these adverse effects.

The study indicates that using a focal ischemia model in rats could help predict the increased sensitivity of stroke patients to NMDA antagonists, which may aid in developing safer treatments that minimize harmful side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal ischemia enhances the adverse effect potential of N-methyl-D-aspartate receptor antagonists in rats. Löscher, W., Wlaź, P., Szabo, L.[2019]

GV150526, a novel glycine antagonist at the NMDA receptor, was generally well tolerated in a trial involving 128 patients with acute stroke, indicating its safety for further study.

While the trial showed some imbalances in patient outcomes and adverse events, particularly with the lower maintenance dose, the results suggest that GV150526 warrants further investigation for its potential efficacy in treating acute stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycine antagonist (GV150526) in acute stroke: a multicentre, double-blind placebo-controlled phase II trial. Lees, KR., Lavelle, JF., Cunha, L., et al.[2022]

In the CHIMES Study, the Philippine cohort of 504 patients showed a significant treatment effect in favor of MLC601 compared to placebo, with an adjusted odds ratio of 1.41 for improved outcomes on the modified Rankin Score at three months.

The Philippine patients had worse baseline stroke severity and longer delays in treatment initiation, suggesting that MLC601 may be particularly beneficial for patients with poorer prognostic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics and treatment response of patients from the Philippines in the CHIMES study. Navarro, JC., Gan, HH., Lao, AY., et al.[2014]

Pilot studies of Org 10172 for treating acute ischemic stroke have identified a potentially optimal dosage and treatment regimen, paving the way for further research.

A large randomized trial of Org 10172 is currently being conducted in the United States to evaluate its efficacy in managing acute ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Studies of Org 10172 in patients with acute ischemic stroke. TOAST Study Group. Adams, HP., Woolson, RF., Biller, J., et al.[2018]

The Park Sham Device, designed for acupuncture trials, was found to be indistinguishable from real acupuncture needles in acupuncture-naïve subjects, making it a valid control for clinical studies.

The sham procedure was inactive, as evidenced by a significantly lower incidence of the specific needle sensation (de qi) compared to real acupuncture, supporting the concept of de qi in traditional Chinese acupuncture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Park, J., White, A., Stevinson, C., et al.[2022]

Scalp acupuncture significantly improved neurological function and reduced vasogenic edema in spontaneously hypertensive stroke-prone (SHR-SP) rats, indicating its potential efficacy for strokes caused by hypertension.

However, scalp acupuncture did not show significant effects on cytotoxic edema or neurological dysfunction in rats with transient focal cerebral ischemia (MCAO), suggesting it may be less effective for ischemic strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalp acupuncture effects of stroke studied with magnetic resonance imaging: different actions in the two stroke model rats. Inoue, I., Fukunaga, M., Koga, K., et al.[2009]

Scalp acupuncture (SA) therapy has been shown to significantly improve recovery from strokes, particularly in reducing paralysis and speech disturbances, with a recovery rate that is twice as high compared to medication alone.

In a study using a specific rat model for stroke, SA demonstrated rapid and effective removal of limb paralysis caused by both cerebral infarcts and hemorrhages, suggesting strong therapeutic potential that can be further explored alongside clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproduction of scalp acupuncture therapy on strokes in the model rats, spontaneous hypertensive rats-stroke prone (SHR-SP). Inoue, I., Chen, L., Zhou, L., et al.[2019]

In a double-blind, placebo-controlled trial involving 150 patients with recent ischemic stroke, MLC601 (NeuroAid) significantly improved motor recovery compared to placebo, as measured by the Fugl-Meyer assessment over 12 weeks (P < .001).

The treatment was well-tolerated, with only mild and transient adverse events reported, indicating that MLC601 is a safe addition to standard stroke therapies, particularly for patients with moderate to severe strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial. Harandi, AA., Abolfazli, R., Hatemian, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Superiority of Rehabilitative Treatments in Enhancing Motor Recovery Within 6 Months Poststroke: A Systemic Review. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term levodopa administration in chronic stroke patients. A clinical and neurophysiologic single-blind placebo-controlled cross-over pilot study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Preliminary study of the effects of a placebo chiropractic treatment with sham adjustments. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Evaluating the efficacy of acupuncture in defined aspects of stroke recovery: a randomised, placebo controlled single blind study. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Chinese medicine NeuroAiD efficacy stroke recovery-extension study (CHIMES-E study): an observational multicenter study to investigate the longer-term efficacy of NeuroAiD in stroke recovery. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

New pathways for evaluating potential acute stroke therapies. [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Phase II studies of the glycine antagonist GV150526 in acute stroke : the North American experience. The North American Glycine Antagonist in Neuroprotection (GAIN) Investigators. [2019]

8. Ireland pubmed.ncbi.nlm.nih.gov

Focal ischemia enhances the adverse effect potential of N-methyl-D-aspartate receptor antagonists in rats. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Glycine antagonist (GV150526) in acute stroke: a multicentre, double-blind placebo-controlled phase II trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Baseline characteristics and treatment response of patients from the Philippines in the CHIMES study. [2014]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Studies of Org 10172 in patients with acute ischemic stroke. TOAST Study Group. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Scalp acupuncture effects of stroke studied with magnetic resonance imaging: different actions in the two stroke model rats. [2009]

14. Ireland pubmed.ncbi.nlm.nih.gov

Reproduction of scalp acupuncture therapy on strokes in the model rats, spontaneous hypertensive rats-stroke prone (SHR-SP). [2019]

15. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial. [2022]