770 Participants NeededMy employer runs this trial

Votoplam for Huntington's Disease

(INVEST-HD Trial)

Recruiting at 9 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose is to assess safety and tolerability of votoplam and to determine whether votoplam slows disease progression in patients with early symptomatic Huntington's disease (HD) compared to the control arm.

HTT227 - current compound code (former code is PTC518 from PTC Therapeutics), HTT227 is Novartis code under Novartis sponsorship.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have Huntington's disease with a CAG repeat length of 40 or more.
Signed informed consents must be obtained prior to participation in the study
Meets all of the following criteria: UHDRS IS score ≥90, UHDRS TFC score = 13, UHDRS TMS score = 7-25, inclusive, CAP100 ≥ 70 Calculation: CAP = Age at study entry × (CAG length - 30) / 6.49
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Exclusion Criteria

Women of childbearing potential are excluded unless they are using highly effective methods of contraception while taking study treatment and for 8 months after stopping study treatment, Pregnant or nursing (breastfeeding) women
I have a history of serious heart rhythm problems or inherited heart conditions.
I have had gene therapy, cell transplant, or experimental brain surgery for Huntington's disease.
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What Are the Treatments Tested in This Trial?

Interventions

  • Votoplam

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: VotoplamExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD