Other

D-Cycloserine for Fibromyalgia

Q: How many participants are currently engaged in this medical trial?

<p>Affirmative. Clinicaltrials.gov reveals that this <a href="https://www.withpower.com/clinical-trials/sci">sci</a>entific experiment, which was inaugurated on August 29th 2022, is still actively looking for enrollees. Approximately 90 subjects must be recruited at 1 site in total.</p>

Phase 2

Waitlist Available

Led By Alexander McGirr, MD, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of fibromyalgia as per the American College of Rheumatology 2016 fibromyalgia criteria

Score ≥ 41 on the FIQR

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upadministered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)

Awards & highlights

Study Summary

This trial is testing whether using a medication called D-cycloserine in conjunction with transcranial magnetic stimulation (TMS) can help improve symptoms in fibromyalgia patients more than TMS alone.

Eligible Conditions

Fibromyalgia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You have been diagnosed with fibromyalgia based on the criteria set by the American College of Rheumatology in 2016.

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You have a fibromyalgia impact questionnaire score of 41 or higher.

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You have tried and failed to respond to treatment with certain antidepressant medications or therapy, or you were not able to tolerate these treatments.

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You have tried medications and therapy for your condition, but they didn't work or you couldn't tolerate them.

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You have been diagnosed with fibromyalgia based on the American College of Rheumatology's criteria from 2016.

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You have a high score (41 or more) on a questionnaire called the FIQR.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8)

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at baseline, halfway (week 2), after rtms treatment (week 4), and at one month follow up (week 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Differential change in the will be mediated by D-Cycloserine plasma level

Differential change in the will be mediated by fidelity to the protocol

Revised Fibromyalgia Impact Questionnaire (FIQR)

+1 more

Secondary outcome measures

Change in Anxiety as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29)

Change in Central Sensitization Pain as measured by the The Central Sensitization Inventory (CSI)

Change in Cognitive Function - THINC-integrated tool (THINC-it)- Choice Reaction Time

+42 more

Other outcome measures

Incidence of Treatment-Emergent Adverse Events

Side Effects

Side effects data

From 2012 Phase 4 trial • 169 Patients • NCT00633984

General

Neurological

Other

Cognitive/Emotional

100%

80%

60%

40%

20%

Study treatment Arm

Cognitive Behavioral Therapy + DCS

Cognitive Behavioral Therapy + Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: D-CycloserineExperimental Treatment2 Interventions

Participants will orally ingest a capsule containing 100mg of the antibiotic d-cycloserine daily (Monday-Friday) during 4 weeks of rTMS treatment (20 sessions) 60-120 minutes prior to rTMS treatment.

Group II: PlaceboPlacebo Group2 Interventions

Participants will orally ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule daily (Monday-Friday) for 4 weeks of rTMS treatment (20 sessions) 60 - 120 minutes prior to rTMS treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

D-Cycloserine

2011

Completed Phase 4

~1850

0 / 6Eligibility criteria met

Find a site

Who is running the clinical trial?

University of CalgaryLead Sponsor

748 Previous Clinical Trials

583,240 Total Patients Enrolled

Alexander McGirr, MD, PhDPrincipal Investigator

University of Calgary

2 Previous Clinical Trials

101 Total Patients Enrolled

Media Library

iTBS-DCS (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05395494 — Phase 2

Fibromyalgia Research Study Groups: D-Cycloserine, Placebo

Fibromyalgia Clinical Trial 2023: iTBS-DCS Highlights & Side Effects. Trial Name: NCT05395494 — Phase 2

iTBS-DCS (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05395494 — Phase 2

Fibromyalgia Patient Testimony for trial: Trial Name: NCT05395494 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any adverse effects associated with D-Cycloserine consumption?

"As this is a Phase 2 trial, indicating that there have been some studies conducted to evaluate the safety of D-Cycloserine, our team at Power judged it to be a score of 2. Yet, no clinical data exists in regard to its efficacy yet."

Answered by AI

What aims does this investigation seek to accomplish?

"The primary outcome measure of this clinical trial, to be assessed over an 8-week period, is the Revised Fibromyalgia Impact Questionnaire (FIQR). Secondary outcomes include Change in Cognitive Function - THINC-integrated tool (THINC-it)- Digit Symbol Substitution Test and Change in Social Function as measured by Patient Reported Outcomes Measurement Information System (PROMIS-29), as well as Neuromelanin differences between healthy controls and fibromyalgia patients detected via MRI scans."

Answered by AI

Who fits the criteria for participation in this experiment?

"This study requires 90 individuals suffering from fibromyalgia, ranging between 18 and 65 years of age. Primary criteria for eligibility include: attaining a score ≥41 on the FIQR; having an American College of Rheumatology-approved fibromyalgia diagnosis; being capable to provide informed consent; not receiving any psychotropic medications in the 4 weeks prior to randomization or failing to respond adequately to serotonin reuptake inhibitors, norepinephrine reuptake inhibitors, or cognitive behavioural therapy; passing TMS adult safety screening (TASS) as well as MRI screening questionnaire; possessing reliable blood work results within last month that are"

Answered by AI

How many participants are currently engaged in this medical trial?

"Affirmative. Clinicaltrials.gov reveals that this scientific experiment, which was inaugurated on August 29th 2022, is still actively looking for enrollees. Approximately 90 subjects must be recruited at 1 site in total."

Answered by AI

Does this experiment include participants aged fifty-five and younger?

"Patients that meet the age criteria of 18 years or older but below 65 can participate in this research."

Answered by AI

Are researchers still recruiting participants for this experiment?

"Per the clinicaltrials.gov website, enrollment for this trial is ongoing and was first advertised on August 29th 2022 with recent updates posted as of November 9th 2022."

Answered by AI