NCT00086294

ACP-103 to Treat Parkinson's Disease

Completed Phase 2 Last updated 2 July 2017

What this trial tests

Phase 2 trial testing Intravenous Levodopa in Parkinson's Disease in 40 participants. Completed in 15 November 2007.

Timeline

25 June 2004

15 November 2007

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	40
Start date	25 June 2004
Estimated completion	15 November 2007
Sites	1 location across United States

Drugs / interventions tested

• Intravenous Levodopa — full drug profile →
• ACP-103 — full drug profile →

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →
• Dyskinesias — all drugs for Dyskinesias →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

Adults 30 to 80, any sex, with Parkinson's Disease or Dyskinesias. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson's disease.

Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study. Candidates are screened with a complete medical history and physical examination, neurological evaluation, blood and urine tests, and electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest x-ray may be done if medically indicated.

Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications for one month (2 months for Selegiline) before the study begins and throughout its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip (ropinirole).

Levodopa Dose Finding

After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely during the infusions, and parkinsonian symptoms are evaluated frequently during and after the infusions. The infusions usually begin early in the morning and continue until evening. Once the infusion is finished, patients resume taking their regular oral Sinemet dose. The infusions are repeated once a week during 1-day inpatient evaluations.

Treatment

Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or changes in their condition. They also have an infusion of levodopa (see above) at the previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours. At the end of the infusions and ratings, patients are discharged home with their regular Parkinson's medications until the following visit.

Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of serotonin 5-HT2A receptors in memory and cognition.
   Zhang G, Stackman RW. · · 2015 · cited 237× · PMID 26500553 · DOI 10.3389/fphar.2015.00225
2. Neurophysiological Treatment Effects of Mesdopetam, Pimavanserin and Amantadine in a Rodent Model of Levodopa-Induced Dyskinesia.
   Ronaghi A, Stan TL, Barrientos SA, Halje P, et al · · 2025 · PMID 40042199 · DOI 10.1111/ejn.70032
3. Pimavanserin: A Truly Effective Treatment for Parkinson’s Disease Psychosis? A Review of Interventions
   Heim B, Peball M, Krismer F, Djamshidian A, et al · · 2023