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ACR16 · 2 trials · 2 indications
The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS include dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items are rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranges from 0 to 52, with higher scores indicating more severe motor impairment.
The mMS is a subscale of the UHDRS total motor score and comprises 13 responses from the 10 items, 4-10 and 13-15, from the UHDRS motor assessment. The items for mMS included dysarthria, tongue protrusion, finger taps (right and left), pronate/supinate hands (right and left), luria - first-hand-palm sequencing, arms rigidity (right and left), body bradykinesia, gait, tandem walking, and retropulsion pull test. Each of these items were rated on a scale of 0 (normal) to 4 (marked impairment). Total score ranged from 0 to 52, with higher scores indicating more severe motor impairment. The last observation carried forward (LOCF) method was used to generate an mMS score for each participant for Week 12 assessment.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants will receive a placebo capsule matching to ACR16 once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), placebo capsule will be taken twice daily as 2 separate doses. |
| ACR16 45 mg | EXPERIMENTAL | Participants will receive ACR16 45 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), one ACR16 45 mg capsule and one placebo capsule will be taken as 2 separate doses. |
| ACR16 90 mg | EXPERIMENTAL | Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 26), ACR16 45 mg capsule will be taken twice daily as 2 separate doses (total dose: 90 mg) |
| ACR16 10 mg BID | EXPERIMENTAL | Participants will receive ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 20 mg). |
| ACR16 22.5 mg BID | EXPERIMENTAL | Participants will receive ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 45 mg). |
| ACR16 45 mg BID | EXPERIMENTAL | Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 90 mg). |
| Name | Type | Description |
|---|---|---|
| ACR16 | DRUG | Capsules will be swallowed whole with water. |
| Placebo | DRUG | Capsules will be swallowed whole with water. |
Inclusion Criteria: * Able to provide written Informed Consent prior to any study related procedure. * Huntington's disease diagnosed with the aid of clinical features and a positive family history and/or the presence of ≥ 36 CAG repeats in the Huntington gene. * Male or female age ≥ 30 years. * Wi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Votoplam |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE3 | Valbenazine |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE1 | ALN-HTT02 |
| uniQure N.V. | QURE | 2 | PHASE1 | intra-striatal rAAV5-miHTT |
| Sarepta Therapeutics, Inc. | SRPT | 1 | PHASE1 | SRP-1005 |
ACR16, also known as pridopidine, is an investigational small molecule being developed for the treatment of Huntington's disease, a neurodegenerative disorder. It is being studied to assess its effects on motor symptoms and overall disease progression in patients with this condition.
ACR16 is being developed by Teva Pharmaceutical Industries Limited, a global pharmaceutical company. Teva is conducting clinical trials to evaluate the safety and efficacy of this drug for Huntington's disease.
ACR16 has completed Phase 2 and Phase 3 clinical trials for Huntington's disease. The Phase 3 trial, NCT00665223, enrolled 437 participants and was completed, while the Phase 2 trial, NCT00724048, enrolled 227 participants and was also completed. ACR16 remains investigational and is not yet approved.
ACR16 has been studied in two completed clinical trials. NCT00665223 was a Phase 3 study in Huntington's disease with 437 participants across Europe, and NCT00724048 was a Phase 2 study in Huntington disease with 227 participants in the United States and Canada. Both were randomized, double-blind, and placebo-controlled.
Yes, ACR16 is also known as pridopidine. The drug is referred to by both names in clinical research, with ACR16 being the compound identifier and pridopidine being the generic name used in trial titles and publications.