An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

Main measures

• Number of Participants With Peripheral Edema

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Facial/Periorbital Edema

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Generalized or Abdominal Edema

  Baseline, Weeks 4, 20, 36, 52, and 53

• Number of Participants With Localized Pain Related to Deep Vein Thrombosis (DVT)

  Baseline, Weeks 4, 20, 36, 52, and 53

  Pain

• Number of Participants With Localized Tenderness Related to Deep Vein Thrombosis (DVT)

  Baseline, Weeks 4, 20, 36, 52, and 53

  Pain

• Number of Participants With Swelling Related to Deep Vein Thrombosis (DVT)

  Baseline, Weeks 4, 20, 36, 52, and 53

  Pain

• Number of Participants With Pitting Edema Related to Deep Vein Thrombosis (DVT)

  Baseline, Weeks 4, 20, 36, 52, and 53

  Pain

• Number of Participants With Collateral Superficial Veins (Non-varicose) Related to Deep Vein Thrombosis (DVT)

  Baseline, Weeks 4, 20, 36, 52, and 53

  Pain

• Number of Participants With Skin Redness Related to Deep Vein Thrombosis (DVT)

  Baseline, Weeks 4, 20, 36, 52, and 53

  Pain

• Number of Participants With Visual Field Deteriorated

  53 weeks

• Number of Participants With Deterioration in Neurological Examination Findings

  53 weeks

  Walking and mobilityPhysical function

• Number of Participants With Suicidal Ideation According to Sheehan Suicidality Tracking Scale (Sheehan-STS)

  Baseline, Weeks 2, 4, 8, 12, 20, 28, 36, 44, and 52

MS (type not specified) · 18 and over

As registered. Criteria can change, so ask the trial team or your neurologist.

In the sponsor's words

• Results

  Ogawa S, Arakawa A, Hayakawa K, Yoshiyama T. Pregabalin for Neuropathic Pain: Why Benefits Could Be Expected for Multiple Pain Conditions. Clin Drug Investig. 2016 Nov;36(11):877-888. doi: 10.1007/s40261-016-0423-x.

• Results

  Onouchi K, Koga H, Yokoyama K, Yoshiyama T. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. J Pain Res. 2014 Jul 28;7:439-47. doi: 10.2147/JPR.S63028. eCollection 2014.

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1. Started

   Sept 2010

2. Main results due

   Mar 2012

3. Finished

   Mar 2012

4. Results posted

   May 2013