M15-741 - SC ABBV-951 in subjects with Parkinson's disease

• Research type

  Research Study

• Full title

  A 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease

• IRAS ID

  259894

• Contact name

  K Ray Chaudhuri

• Contact email

  ray.chaudhuri@nhs.net

• Sponsor organisation

  AbbVie Ltd

• Eudract number

  2018-002144-85

• Clinicaltrials.gov Identifier

  NCT03781167

• Duration of Study in the UK

  2 years, 0 months, 4 days

• Research summary

  Parkinson’s disease (PD) is a neurological condition, which means it affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. People with Parkinson's do not have enough of the chemical dopamine because some of the nerve cells that make it have died. In most of the cases the cause of PD is unknown, which is called idiopathic Parkinson’s disease. The most common symptoms of idiopathic Parkinson’s are tremor, stiffness and slowness of movement.

  Levodopa (LD)/carbidopa (CD) combination products are approved for the control of motor symptoms and are provided as oral tablets or as an intestinal (gut) gel via surgically installed portable pump.

  ABBV-951 is an investigational (unapproved) drug containing a form of LD/CD delivered via subcutaneous infusion (under the skin) 24 hours daily for 52 weeks.
  ABBV-951 has the potential to achieve similar results to the LD/CD intestinal gel and delivering the LD/CD drug via a less invasive approach.
  This new treatment may provide another option to many patients whose motor symptoms are not very well controlled by their current treatment.
  This is a Phase 3 open-label (treatment type is known to patients and doctors), single arm study, which will be conducted at approximately 65 sites worldwide, including three sites in the UK.

  Patients will receive ABBV-951 continuously throughout the study for a period of up to 52 weeks.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  19/LO/1220

• Date of REC Opinion

  29 Jul 2019

• REC opinion

  Favourable Opinion